Principal Engineer, Manufacturing Science and Technology (Biotech)

TL;DR

Principal Engineer, Manufacturing Science and Technology (Biotech): Provide technical and strategic leadership for CAR-T manufacturing from late-stage development through commercialization with an accent on Process Performance Qualification (PPQ) planning and execution. Focus on developing PPQ strategies, protocols, cross-functional alignment, and ensuring timely product release.

Onsite at headquarters in South San Francisco or manufacturing facility in Newark, CA. Candidates must be authorized to work in the U.S. Ability to travel up to 10%.

Salary: $150,000–$170,000 per year

Company

Clinical-stage biotechnology company pioneering allogeneic CAR T cell (AlloCAR T) therapies for cancer and autoimmune diseases.

What you will do

• Develop strategy for Process Performance Qualification (PPQ) in partnership with Quality, Process Development, and Regulatory for licensing applications.
• Lead PPQ-enabling activities including Process Control Strategy, PPQ protocol, and extractables & leachables (E&L) assessment.
• Ensure cross-functional alignment with Quality, Facilities & Engineering, Process Development, and IT.
• Partner with Quality Assurance to manage timely review and release of products.
• Collaborate with manufacturing team to achieve department goals.

Requirements

• Bachelor’s degree in Science or Engineering with at least 8 years of GMP pharmaceutical manufacturing experience (CAR-T strongly preferred).
• Knowledge of pharmaceutical manufacturing processes (cell therapy preferred).
• Late-stage clinical and commercial experience (CMC regulatory submissions preferred).
• Strong leadership skills to organize and lead teams without direct reports.
• Excellent organizational, prioritization, interpersonal, and communication skills.
• Authorized to work in the U.S.

Culture & Benefits

• Collaborative environment with talented team focused on delivering lifesaving therapies.
• Competitive compensation including annual performance bonus and equity.
• Health insurance, generous time off, and two annual company-wide holiday shutdowns.